Study of Hydration Levels in Sports and Non-sports School... | NCT06170554

Studies
Study of Hydration Levels in Sports and Non-sports Schoolchildren (EHC)

NCT06170554

Sponsor

University Hospital, Brest

Status

Unknown status

Last Update Posted

Apr 17, 2024Actual

Enrollment

259Actual

Phase

Not provided

Conditions

Hydration

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 16, 2023Actual

Primary Completion Date

Jul 31, 2024Estimated

Completion Date

Oct 31, 2024Estimated

First Submitted Date

Nov 23, 2023

First Submission Date that Met QC Criteria

Dec 12, 2023

First Posted Date

Dec 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2024

Last Update Posted Date

Apr 17, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

New knowledge regarding the negative impact of poor hydration on health highlights the need to provide recent epidemiological data on the water intake of the French population, especially among middle school students, a group that has been minimally studied until now. Given the crucial role of adequate hydration in sports performance, it is essential to assess fluid intake and hydration habits among middle school students, who often engage in intense physical activities. The primary outcome of this study is to evaluate whether the proportion of middle school students hydrating adequately according to current recommendations is higher among those engaging in moderate to intense sports compared to those who do little or no sports. The goal is to determine if daily fluid intake is significantly influenced by physical activity among this population. To achieve this, investigators have developed a questionnaire to gather information on the physical activity levels of middle school students, their daily hydration habits, and their liquid intake in relation to their sports activities, using appropriate visuals. This study involves distributing the questionnaire in two middle schools in Brittany between November 2023 and January 2024.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

259Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of middle school students adhering to current hydration recommendations among both athletic and non-athletic middle school students	Response to the questionnaire	baseline

Secondary Outcomes

Measure	Description	Time Frame
Proportion of middle school students adhering to current hydration recommendations	Response to the questionnaire	baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Middle school students with little or no sports involvement and middle school students with a moderate to intense level of physical activity

Exclusion Criteria:

Refusal of the middle school student to participate and parental opposition to their child's participation in this research

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

The studied population includes middle school students from two classes of 6th, 5th, 4th, and 3rd grades at Sainte Anne College in Brest, as well as middle school students from two classes of 6th, 5th, 4th, and 3rd grades at Pays des Abers College in Lannilis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marie-Agnes Giroux-Metges, MD PhD	Universitary Hospital of Brest	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest		Brest		29609	France

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All collected data that underlie results in a publication

Types

Study Protocol

Time Frame

Data will be available beginning three years and ending fifteen years following the final study report completion

Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003681	Dehydration

Ancestor Terms

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided